Value of Ultrasound for Evaluating Rheumatoid Arthritis in Remission: Longitudinal Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis in Remission
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- 1 year pejorative evolution
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The objective of this study is to determine the longitudinal relation between clinical remission and ultrasound (US) remission in Rheumatoid arthritis (RA).
At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals and power Doppler signals) is frequent in patients with RA in clinical remission. Several longitudinal studies reveal an association of US-detected residual synovitis and risk of relapse and radiographic progression, in individual patients and joints, over 1-2 years.
However, the longitudinal relation between clinical remission and US remission is not so well-known and it is possible that clinical remission arrive before ultrasound remission. Thus arise the question as to whether the presence of US-detected residual synovitis require to adapt the treatment to ultrasound findings or to simply increase the patient care.
The investigator propose to conduct a prospective, bi-center, non randomized study.
Detailed Description
The study population will include all RA patient at least 18 years old in clinical remission for less than 6 month. The primary endpoint (ability of US-detected residual synovitis to predict relapse or radiographic progression in individual patients and joints) will be evaluated afer 12 months of follow-up The total follow-up will be 12 months with a follow-up every 3 months. In addition to the standard care, each follow-up will include an ultrasound examination of 40 joints and 8 tendons
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •PR fulfilling ARC / EULAR (European League Against Rheumatism) 2010 criteria
- •Patient treated by DMARDs (disease-modifying antirheumatic drug)
- •Patient in confirmed remission for less than 6 months
Exclusion Criteria
- •Patient participating simultaneously in another clinical study with blind treatment
- •Patient participating simultaneously in another clinical study involving decreasing of drug dose
- •Patient in post clinical study exclusion period
- •patients subject to legal protection measures
- •Patient unable to read French
- •Pregnant or breast-feeding women
- •patient treated with Rituximab
Outcomes
Primary Outcomes
1 year pejorative evolution
Time Frame: 1 year after inclusion
Number of patient with a clinical relapse
Secondary Outcomes
- Structural progression(1 year after inclusion)
- RA (Rheumatoid Arthritis) remission duration(At each follow-up (3,6,9 and 12 months after inclusion))
- RA ultrasound remission duration(At each follow-up (3,6,9 and 12 months after inclusion))
- RA clinical remission duration(At each follow-up (3,6,9 and 12 months after inclusion))
- Clinical relapse at one year(1 year after inclusion)
- Persistence of ultrasound synovitis (lenght of RA evolution, lenght of clinical remission, anti-CCP, biological inflammatory symptom persistence, treatments)(At baseline)
- Radiographic progression at 1 year(1 year after inclusion)
- Intra-observator reproductibility(1 year after inclusion)